MedPath

Belapectin

Generic Name
Belapectin
Drug Type
Small Molecule
CAS Number
1980787-47-0
Unique Ingredient Identifier
K7ODU55HT6
Background

Belapectin is under investigation in clinical trial NCT02575404 (GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients).

Clinical Trials
Related News

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• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

Liver Cirrhosis Clinical Trial Pipeline Gains Momentum

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Hepatology Review: FDA Updates, Viral Hepatitis Research, and MASH Advancements in December 2024

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Belapectin Shows Significant Reduction in New Varices in U.S. MASH Cirrhosis Patients

• Belapectin demonstrates a statistically significant 68.1% reduction in the incidence of new varices compared to placebo in U.S. patients with MASH cirrhosis and portal hypertension. • The analysis comes from the NAVIGATE trial, focusing on per-protocol patients (completers) enrolled in the U.S., highlighting the drug's potential in this subgroup. • An estimated 3 million adults in the U.S. suffer from MASH cirrhosis with clinically significant portal hypertension, an area with no FDA-approved therapies. • Further analysis of the NAVIGATE trial, including data from patients completing 36 months of treatment, is expected by the end of Q1 2025.

Galectin Therapeutics' Belapectin Fails to Meet Primary Endpoint in MASH Cirrhosis Trial

• Galectin Therapeutics' NAVIGATE trial of belapectin in MASH cirrhosis patients with portal hypertension did not meet its primary endpoint of preventing varices. • While belapectin reduced varices incidence in the intent-to-treat population, the difference was not statistically significant compared to placebo. • In a per-protocol analysis, belapectin showed a 48.9% reduction in varices, but this fell short of the targeted 52.5%. • The safety profile of belapectin remains encouraging, with adverse events comparable to placebo; further analysis and 36-month outcomes are pending.

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